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CompletedNCT00989534EW and EWDUpdated Oct 3, 2016

Extended Work Schedules, Sleep Loss and Health

An interventional study of Fixed restricted bedtimes and Sleep restriction with circadian misalignment in Sleep, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 21 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-03.

Sponsored by University of Chicago · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
21 Years to 39 Years
Sex
All
01

Study summary

This study aims to determine whether abnormal bodily rhythms contribute to elevate the risk of diabetes, independently of the amount of sleep loss.

02

Conditions studied

  • Sleep

Keywords

  • shift work
  • diabetes
  • Affects of shift work and sleep loss on health
03

In context

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • normal healthy men and women between the ages of 21 years and 39 years (inclusive) with normal weight (i.e., body mass index under 28 kg/m2 in men, 27 kg/m2 in women)
  • normal findings on clinical examination, normal results on routine laboratory tests, normal EKG, normal glucose tolerance test, negative pregnancy test for women
  • no personal history of psychiatric or endocrine illness
  • no personal history of sleep disorder, usual total sleep time of at least 7 hours
  • only female volunteers with normal ovulatory cycles will be included

Exclusion criteria

Exclusion Criteria:

  • subjects with irregular life habits (shiftworkers and subjects having traveled across time zones less than one month prior to the beginning of the baseline study)
  • subjects taking any medication (including hormonal contraceptive therapy), and smokers are excluded
  • subjects with significant sleep apnea (apnea index above 10) or significant arousal-associated periodic leg movements are excluded
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Sleep loss and circadian alignment

    Sleep restriction without circadian misalignment

    Behavioral: Fixed restricted bedtimes

  • Experimental
    Sleep loss and circadian misalignment

    Behavioral: Sleep restriction with circadian misalignment

Interventions

  • BehavioralFixed restricted bedtimes

    Sleep restricted to 5 hours per night for 8 nights

  • BehavioralSleep restriction with circadian misalignment

    Sleep restricted to 5 h per day for 8 days, alternating night sleep and day sleep

06

Study locations

1 site
  • The University of Chicago
    Chicago, Illinois 60637, United States
07

References and documents

Publications

  • Leproult R, Holmback U, Van Cauter E. Circadian misalignment augments markers of insulin resistance and inflammation, independently of sleep loss. Diabetes. 2014 Jun;63(6):1860-9. doi: 10.2337/db13-1546. Epub 2014 Jan 23. PubMed 24458353 ↗
  • Grimaldi D, Carter JR, Van Cauter E, Leproult R. Adverse Impact of Sleep Restriction and Circadian Misalignment on Autonomic Function in Healthy Young Adults. Hypertension. 2016 Jul;68(1):243-50. doi: 10.1161/HYPERTENSIONAHA.115.06847. Epub 2016 Jun 6. PubMed 27271308 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00989534
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Oct 5, 2009
Start date
Jan 2003
Primary completion
Dec 2007
Completion
Sep 2009
Last update
Oct 3, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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